Guest Skeptic: Dr. Alfred Sacchetti is a full time practicing Emergency Physician, who is also the Chief of Emergency Medicine at Our Lady of Lourdes Medical Center in Camden, New Jersey, USA, an Assistant Clinical Professor of Emergency Medicine, an Active Researcher and faculty member for the Emergency Medicine and Acute Care course.

Case: 40-year-old male appears with what he describes as his typical migraine that has failed his usual home therapies. In the emergency department after six hours and multiple medications, the patient’s pain is finally under control. While being discharged he asks if there anything you can offer to prevent headaches from coming back. He states: “I have to fly to Chengdu University of Traditional Chinese Medicine next week on a sales call and don’t want to have the headache return while I am there.”

Background: More than 10% of people (6% men and 18% women) suffer from migraines. This condition represents a significant source of both medical costs and lost productivity. Direct costs are estimated at approximately 17 billion dollars a year. There are also indirect costs of about 15 billion dollars a year mainly due to missed work.

There are many options for treating migraine headaches in the emergency department. When every you see so many treatments for the same problem it is an indication that none of them work very well. One of the best treatment options is just to give the patient a quiet/dark space and time to get some sleep. If that does not work, one good therapy to try is IV metoclopramide. A very good drug that is no longer widely available is droperidol. Sometimes opioids are required to treat bad headaches in the emergency department.

We have covered ketorolac on SGEM#66 as a possible therapy for acute migraine in the emergency department. The bottom line from that episode was that ketorolac is a reasonable second-line agent. Don’t forget that there is a ceiling effect for NSAIDs that was covered with Chris Bond SGEM#175 featuring a paper by Sergey Motov.

Up to half of patients presenting to the emergency department with their migraines will “bounce-back” to the emergency department within a few days. Dexamethasone has been tried in randomized control trials to prevent bounce-backs.

We covered a SRMA by Coleman et al from the BMJ on SGEM#28: Bang Your Head. It showed that a single parenteral dose of dexamethasone ≥15mg for successfully aborted migraine will significantly reduce early recurrences (NNT=9) with no significant side effects.

The authors of this study felt that because acupuncture has been known to treat migraines, it may also have a role in preventing them as well.

There was a Cochrane review in 2009 [1] that found “There is no evidence for an effect of ‘true’ acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance.”

They updated their review in 2016 [2] and claimed acupuncture now did work. Of the studies that included a sham acupuncture group the effect size was small but statistically significant. However, the quality of the evidence was moderate and there was moderate heterogeneity.

Standard Mean Difference:

-0.18 (95% CI -0.28 to -0.08; I2 = 47%) after treatment

-0.19 (95% CI -0.30 to -0.09; I2 = 59%) at follow-up

This small statistical difference might not be clinically significant and could be explained by the lack of blinding of the provider in the studies. This could increase the placebo effect.

Clinical Question: Does treating patients who have migraines without aura with acupuncture prevent the re-occurrence of migraine headaches?

Population: Patients 18 to 65-years-old with documented migraine without aura as classified by the International Headache Society [3] and migraine attacks of two to eight per month in the last three months.

Exclusions: Patients were excluded if their headache was caused by an organic disorder; the presence of neurological disease, immunodeficiency, bleeding disorder, or allergy; prophylactic headache treatment with drugs during the previous three months; pregnancy, lactation, or plans to become pregnant within six months.

Intervention: Electrostimulation acupuncture (frequency 2/100 Hz with an intensity from 0.1 to 1.0 mA) at four acupuncture sites to achieve Deqi sensation. They defined Deqi as a sensation of soreness, numbness, distention or radiating that indicates effective needling. The electrostimulation acupuncture was performed once per day for thirty minutes, five days a week for four weeks.

Comparison:

Sham Acupuncture: Same number of needles, electric stimulation and duration of treatment but in four non-points as to NOT to induce the Deqi sensation.

No Treatment: This group of patients received no treatment but were told they would be provide with 20 acupuncture sessions for free but had to wait for 24 weeks.

Outcome:

Primary: Change in frequency of migraine attacks between baseline and 16 weeks after randomization

Secondary: Number of days with migraine, average headache severity, and medication intake every four weeks within 24 weeks. In addition, migraine-specific quality-of-life questionnaire, pain-related impairment of emotion and self-rating depression scale.

Authors’ Conclusions: “Among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to waiting list.”

Quality Checklist for Randomized Clinical Trials:

The study population included or focused on those in the emergency department. No. These were clinical patients.

The patients were adequately randomized. Yes

The randomization process was concealed. Yes

The patients were analyzed in the groups to which they were randomized. Yes

Migraine attacks frequency, migraine days, and VAS scores were significantly lower in the TA group than in the other two control groups.

Figure 2 is a graph showing the frequency of migraine attacks throughout the study. It is difficult to interpret because it lacks error bars. What it seems to show is a placebo effect, but we will discuss that more in the nerdy section.

Use of acute pain medication was not different between TA and SA

Adverse Events: There were seven patients with adverse events (five in the TA group and two in the SA). All were mild or moderate.

1) Selection Bias/External Validity: These were patients recruited from the Department of Acupuncture and Neurology in three clinical centers not emergency department patients. Patients attending these clinics could have self-selected to attend such a clinic believing acupuncture works. More than 20% of the included population had previously used acupuncture. This could have introduced selection bias into the study.

There is also the problem of external validity. Are these the type of migraine patients we see in the emergency department? They selected migraine patients without aura. It is hard to tell if these are true migraines or some other type of severe headache. Would this treatment apply to the headache patients that present to the emergency department seeking relief?

2) Unbalanced Groups: They said the groups were comparable at baseline. However, looking at Table 1, 43% of the true acupuncture group used acute pain medication compared to only 29% of the sham acupuncture group. It is unclear how this difference could have impacted the results. In addition, there was no difference in the use of pain medication between the true and sham acupuncture group throughout the 24 weeks of the study.

3) Un-Blinded Provider (First Fatal Flaw): The same clinicians were performing both the true and sham acupuncture. Since much of acupuncture’s effects may be related to clinician / patient interaction it is very possible the patient interactions were different between the two groups. Conversation in true acupuncture group “Tell me how much better you are doing since we started these wonderful treatments that I strongly believe will help you.” Sham group “Have the headache really gotten any better since I started stinking needles randomly in your head.” Obviously, the interaction biases would be subtler, but could still exist.

4) Un-Blinding of the Patients (Second Fatal Flaw): They claim that patients were blinded to true vs. sham acupuncture. However, these were patients most likely familiar with acupuncture. The true group were treated with electro-acupuncture to achieve Deqi sensations (a sensation of soreness, numbness, distention, or radiating that indicates effective needling). At the very least this would add a placebo effect to those in the true acupuncture group. I suspect the Deqi sensation in the true acupuncture group could have un-blinded the trial. It would have been easy to confirm blinding simply by asking the patients which group they thought they had been allocated.

5) Strawman Comparison (Third Fatal Flaw): The Acupuncture group all had to have needles placed at points GB20 and GB8 and electrically stimulated until a neurogenic response was generated. Point GB20 is directly over the greater occipital nerve and GB8 is over the auricular nerve, two sites shown to provide migraine relief when injected with anesthetics or simply touched with needles. So, the true acupuncture group is not interacting with any meridians, they are only electrically stimulating (like a TENS unit) over nerves known to relieve migraine headaches. The sham group is just getting needles without electricity and not over nerves that cannot produce the same effect.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We disagree with the authors’ conclusions due to the three fatal flaws in the study design.

SGEM Bottom Line: This study does not provide any evidence of the efficacy of acupuncture to prevent the re-occurrence of migraine headache in patients without aura.

Case Resolution: You offer him a dose of dexamethasone to prevent his headache from re-occurring while away in China.

Dr. Alfred Sacchetti

Clinical Application: Acupuncture for migraine prevention does not have a clinical application in the emergency department.

What Do I Tell My Patient? I’m glad we were able to effectively treat your headache with medication. If you want to prevent the headache from re-occurring in the short term on your trip to China I would recommend a dose of dexamethasone.

Keener Kontest: Last weeks’ winner was Dr. Bryan Greenfield from Baylor College of Medicine in Texas. He knew Utaka Okamoto is credited with the discovery of TXA.

Listen to the SGEM podcast on iTunes to hear this weeks’ question. If you know the answer send an email to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize.